Anchor instrumentation and methods

ABSTRACT

Some embodiments of a medical device anchor system include an anchor sleeve that receives a catheter (or other medical instrument) though a working channel of the anchor sleeve. The anchor sleeve may include a first actuator that controls the extension of one or more subcutaneous tines into the subcutaneous region under the skin. The anchor sleeve can also include a second actuator that can cause the anchor sleeve to lock onto an outer portion of the catheter (or other medical instrument) arrange in the working channel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Application Ser. No.60/978,900, filed on Oct. 10, 2007 by Michael S. Rosenberg et al. andentitled “Anchor Instrumentation And Methods, which is fullyincorporated herein by reference.

TECHNICAL FIELD

This document relates to anchor instrumentation, such as an anchordevice for use in placement of a catheter or other medical instrument.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Following introduction into thepatient, the catheter is secured to the patient. In conventionalpractice, the catheter is commonly secured to the patient using anadhesive tape patch or by suturing an attached hub to the patient'sskin.

SUMMARY

Some embodiments of a medical device anchor system include an anchorsleeve that receives a catheter (or other medical instrument) though aworking channel of the anchor sleeve. The anchor sleeve may include afirst actuator that controls the extension of one or more subcutaneoustines into the subcutaneous region under the skin. The anchor sleeve canalso include a second actuator that can cause the anchor sleeve to lockonto the outer body of the catheter (or other medical instrument)arrange in the working channel.

In some embodiments, an anchor sleeve device may include an elongatebody that defines at least one working channel extending from a proximalopening to a distal tip opening so as to receive a catheter. The anchorsleeve device may also include a subcutaneous anchor mechanism coupledto the elongate body. The subcutaneous anchor mechanism may have one ormore flexible anchors that extend away from the body wall when in adeployed orientation in a subcutaneous layer. The anchor sleeve devicemay include a first actuator that is adjustable relative to the elongatebody so as to shift the flexible anchors to the deployed orientation.The anchor sleeve device may further include a locking device thatreleasably engages to the catheter when the catheter is received in theworking channel. The anchor sleeve device may include a second actuatorthat is adjustable relative to the elongate body so as to urge thelocking device to compress at least a portion of an outer surface of thecatheter when the catheter is received in the working channel.

Some embodiments can include a method of delivering a catheter device toan internal body site. The method may include advancing an anchor sleevethrough a percutaneous opening so that one or more subcutaneous anchortines are disposed adjacent to a subcutaneous region. The method mayalso include advancing a catheter device though a working channel of theanchor sleeve and toward a targeted body site. The catheter device maydefine at least one lumen that extends to a catheter tip. The method mayfurther include operating a first actuator to deploy the subcutaneousanchor tines into the subcutaneous region. Also, the method may includeoperating a second actuator to deploy the subcutaneous anchor tines intothe subcutaneous region to urge a locking device to compress at least aportion of an outer surface of the catheter when the catheter isreceived in the working channel.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of the anchorsleeve may include subcutaneous anchors that retain the anchor sleeve inthe subcutaneous region. For example, the anchors may compriseadjustable tines comprising a material that exhibits superelasticitywhen used in a human body (e.g., Nitinol or the like). The anchors canbe deployed in the subcutaneous region so as to at least temporarilyretain the anchor sleeve in engagement with the patient's body.

Second, some embodiments of the anchor sleeve may include a firstactuator device (e.g., a slider device in particular embodiments) thatcan be actuated to control the extension of the anchors into thesubcutaneous region. As such, the anchor tines can be in a retractedposition (e.g., retracted into the sleeve body) during passage throughthe skin surface. Thereafter, the anchor tines can be controllablyshifted to the extended position under the skin and in the subcutaneousregion so as to anchor the sleeve body to the skin insertion site.

Third, some embodiment of the anchor sleeve may include a secondactuator (e.g., a twist device in particular embodiments) that causesthe anchor sleeve to releasably lock with the catheter (or other medicalinstrument) after the catheter has been advanced through the sleevedevice toward a targeted location. In some circumstances, the lockingdevice can also form a seal around the catheter when connected thereto.In particular, the locking device may comprise a polymeric seal member(e.g., a silicon cylindrical member or the like) that is compressed uponan outer surface of the catheter device in response to the adjustment ofthe second actuator.

Fourth, because some embodiments of the anchor sleeve include a firstactuator to deploy the anchors and a second actuator to cause thelocking engagement, the anchor sleeve can be equipped to isolate thesetwo functions and provide the proper amount of force for each function.For example, the force required to releasably lock the anchor sleevewith the catheter device may be substantially greater than the forcerequired to deploy the anchors in the subcutaneous region. As such, thesecond actuator can be configured to provide a mechanical advantage forthe user so that the locking force is applied in a suitable manner.Also, the first actuator can be configured to deploy the anchors withoutusing an unnecessarily high level of force.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an anchor sleeve being advanced into asubcutaneous region and having a catheter device passing therethrough,in accordance with some embodiments.

FIGS. 2-4 are perspective views of an anchor sleeve in accordance withsome embodiments.

FIGS. 5-7 are bottom views of the anchor sleeve of FIGS. 2-4.

FIGS. 8-10 are cross-sectional views of the anchor sleeve of FIGS. 2-4.

FIG. 11 is a perspective exploded view of adjustable anchor tines and afirst actuator of an anchor sleeve, in accordance with some embodiments.

FIG. 12 is a cross-sectional view of the adjustable anchor tines and thefirst actuator of FIG. 11.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some embodiments of a medical device anchor system 10 include an anchorsleeve 100 and a catheter device 50 (or other medical instrument) toadvance though a working channel 112 of the anchor sleeve 100. Theanchor sleeve 100 may include an elongate body 110, into which thecatheter device 50 can be inserted. The anchor sleeve 100 includes adistal tip portion 115 that may penetrate through a skin entry site 22and into the subcutaneous layer 24 adjacent to the skin 20. Also, thesleeve device 100 includes a proximal portion 116 that can remainexternal to the skin 20 so as to provide an insertion path for thecatheter device 50 or other medical instrument. The catheter device 50is movable relative to the anchor sleeve 100, so the catheter tip 52 canbe advanced through the anchor sleeve 100, into a patient's blood vessel25 (or other body lumen), and toward a targeted body site inside thepatient's body. In such circumstances, the anchor sleeve 100 can be usedto retain the catheter device 50 at the skin entry site 22 on thepatient's skin 20. In particular, the elongate body 110 can releasablyhouse one or more anchors 160. As described in more detail below, theanchors 160 may comprise flexible tines that are deployable into asubcutaneous region 24 under the skin 20 so as to retain the position ofthe anchor sleeve 100 relative to the skin entry point 22.

In this embodiment, the anchor sleeve includes a first actuator 130 thatadjusts the anchors from a non-deployed position to the deployedposition depicted in FIG. 1. The first actuator 130 can be a slidermechanism that reciprocates along a portion of the elongate body 110between a distal position and a proximal position. A user may insert theelongate body 110 through the skin insertion site 22 so that anchordeployment ports (FIG. 5) are arranged under the skin 20 thesubcutaneous region 24. For example, the anchor sleeve 100 may penetratethe skin 20 through a small incision made by a physician. In some casesa dilation instrument may be used to assist in advancing the anchorsleeve 100 through the incision. After insertion, the distal tip portion115 of the anchor sleeve 100 can be advanced into a targeted bloodvessel 25 or other body lumen. When the anchor sleeve 100 is arranged inthe desired position, the user can pull upon the first actuator 130 soas to slide the first actuator from a distal position to the proximalposition shown in FIG. 1. As described in more detail below, theadjustment of the first actuator 130 causes the anchor tines 160 toshift from the non-deployed position to the deployed position shown inFIG. 1.

Still referring to FIG. 1, the anchor sleeve is configured to permit thecatheter device 50 to be delivered through the working channel 112either before the anchor tines 160 are deployed or after the anchortines 160 are deployed. For example, the first actuator 130 can beshifted to cause the deployment of the anchors 160 without necessarilyacting upon the catheter device 50. As such, the catheter device 50 canbe advanced through the working channel 112 of the anchor sleeve 100 todeliver the catheter tip portion 52 to a targeted site inside thepatient's body. When the catheter device 50 is delivered to the targetedsite, the user can initiate a second actuator motion that causes theanchor sleeve 100 to releasably lock with the catheter device 50. Forexample, the anchor sleeve 100 may include a second actuator 140 that isat least partially rotatable relative to the elongate body 110. Thus,the user can impart a twisting motion to the second actuator 140 so asto cause the anchor sleeve 100 to retain the portion of the catheterdevice 50 that is arranged in the working channel 112. In someembodiments, the second actuator 140 may act upon a locking device(FIGS. 8-10) that comprises a polymeric seal member (e.g., a siliconseal). The polymeric seal member (FIGS. 8-10) can be compressed upon anouter surface of the catheter device 50 in response to the adjustment ofthe second actuator 140.

In these embodiments, the operation of first actuator 130 (to deploy theanchors 160) can be independent from the operation of the secondactuator 140 (to cause the locking engagement between the anchor sleeve100 and the catheter device 50). Accordingly, the anchor sleeve 100 canbe equipped to isolate these two functions. For example, the firstactuator 130 can be adjusted to deploy the anchor tines 160 withoutimpeding the insertion or retraction of the catheter device 50. Also,the second actuator 140 can be operated to lock the anchor sleeve 100 inengagement with the catheter device 50 without restricting thedeployment or retraction of the anchor tines 160. Furthermore, theanchor sleeve 100 can be equipped to provide the proper amount of forcefor achieving each function. In some embodiments, the force required toreleasably lock the anchor sleeve 100 with the catheter device 50 may besubstantially greater than the force required to deploy the anchors 160in the subcutaneous region 24. As such, the second actuator 140 can beconfigured to provide a mechanical advantage for the user so that thelocking force is applied in a suitable manner. Also, the first actuator130 can be configured to deploy the anchors 160 without transmitting anunnecessarily high level of force to the anchor tines 160.

Still referring to FIG. 1, the anchor sleeve 100 includes one or moresubcutaneous anchors 160 for use in the temporary anchoring of at leasta portion of elongate body 110 in the subcutaneous layer 24 under theskin 20. In some embodiments, the subcutaneous anchors 160 may comprisea material that exhibits superelasticity when used in the patient'sbody. As such, the subcutaneous anchors 160 can flexibly shift from anon-deployed position (FIG. 2) to a deployed position (FIG. 1) when inthe subcutaneous layer 24. For example, the anchors 60 may be formedfrom a length of nitinol wire or from a sheet of nitinol material, whichhas been processed to exhibit superelasticity below or at about a normalhuman body temperature, such as below or at about 37 degrees C. Thenitinol material may comprise, for example, Nickel Titanium (NiTi),Niobium Titanium (NbTi), or the like. Alternatively, the subcutaneousanchors 160 may comprise a metal material such as stainless steel,spring steel, titanium, MP35N and other cobalt alloys, or the like. Inthese embodiments, the subcutaneous anchors 160 can be formed from amaterial or materials that allow them to be adjustable from thenon-deployed position to the deployed position as shown in FIG. 1.

In some embodiments, the subcutaneous anchors 160 can be flexed to astressed condition when in the non-deployed position (e.g., prior toplacement of the sleeve device 100 in a patient). For example, asdescribed below in connection with FIG. 2, the subcutaneous anchors 160may be retracted into an internal space of the elongate body 110 when inthe non-deployed position. When deployed, as shown in FIG. 1, thesubcutaneous anchors 160 can return to a shape (e.g., by exhibitingsuperelastic characteristics) that allows the subcutaneous anchors 160to at least temporarily retain a portion or all of the body 110 in thesubcutaneous region 24 for a period of time until the treatment with thecatheter device 50 is completed.

As shown in FIG. 1, the subcutaneous anchors 160 may be designed with acurvature that facilitates the transition from the non-deployed to thedeployed position. Furthermore, the curvature of the anchors 160 may beconfigured to eliminate or reduce the potential damage to the skinduring deployment of the anchors 160. For example, the anchors 160 mayinclude a convex curvature that abuts against the underside of the skin20 in a manner that prevents the tips of the anchors 160 from piercingthrough the underside of the skin 20. When the anchors 160 extend fromthe anchor deployment ports 162 (refer to FIGS. 5-7), which arepositioned immediately under the skin 20 in the subcutaneous region 24,the curved shape of the anchors 160 can allow them to deploy adjacent tothe skin 20 without tearing or otherwise damaging it. When deployed, theanchors 160 can serve to retain the elongate body 110 of the sleevedevice 100 relative to the skin entry site 22. In some embodiments, theanchors 160 may provide a holding force of about 1 lb. or greater,depending upon the medical procedure being performed, the materialscomprising the anchors 160, the geometry of the anchors 160, and/orother factors. For example, the anchors 160 may provide a holding forceof about 0.5 lbs or more, about 1 lb to about 20 lbs, about 1 lb toabout 5 lbs, or about 2 lbs to about 3 lbs.

In use, the subcutaneous anchors 160 can be shifted to the non-deployedposition (refer, for example, to FIG. 2) prior to insertion so as tominimize resistance and possible damage to the skin 20 when insertedthrough the skin entry site 22. When the anchor sleeve 100 has beeninserted to the intended depth inside the subcutaneous layer 24, theanchors 160 can be shifted to the deployed position (refer, for example,to FIG. 1) to provide at least temporary anchoring for the anchor sleeve100. When removal of the anchor sleeve device 100 is desired, thesubcutaneous anchors 160 can be shifted back to the non-deployedposition (e.g., by adjustment of the first actuator 130) prior toremoval to minimize resistance and possible damage to the skin 20 andsubcutaneous region 24.

Referring now to FIGS. 2-4, some embodiments of the anchor sleeve 100can be configured to deploy the anchors 160 in an operation that isseparate from the operation of locking the anchor sleeve 100 with thecatheter device 50 (not shown in FIGS. 2-4, refer to FIG. 1). As shownin FIG. 2, the anchor sleeve 100 is in a non-deployed and non-lockedconfiguration. In particular, the anchors 160 are retained inside aninternal space of the elongate body 110 in a non-deployed position. Theelongate body 110 can include a number of anchor deployment ports 162through which the anchors can be extended and retracted in response tomovement of the first actuator 130. In this configuration, the firstactuator 130 is arranged in a distal position (FIG. 2) before it isslidably adjusted to a proximal position (FIG. 3). Also in thisconfiguration, the second actuator 140 is arranged in a first rotationalposition in which it is oriented transverse to the first actuator 130.When the anchor sleeve 100 is in the non-deployed and non-lockedconfiguration (FIG. 2), the distal tip portion 115 can be readilyinserted through the skin insertion site 22 (refer to FIG. 1) withoutinterference from the anchors 160. Furthermore, the catheter device 50(refer to FIG. 1) can be inserted through the working channel 112 of theanchor sleeve 100 when the anchor sleeve 100 is in the non-deployed andnon-locked configuration (FIG. 2). Alternatively, the catheter device 50can be inserted through the working channel 112 after the anchor tines160 are deployed (described below in connection with FIG. 3). Aspreviously described, the catheter device 50 can be advanced through theworking channel 112 of the anchor sleeve 100 and into a blood vessel 25or other body lumen for delivery to a targeted internal site.

As shown in FIG. 3, the anchor sleeve 100 can be adjusted to a deployedand non-locked configuration. In this configuration, the anchors 160 aredeployed from their respective ports 162 so as to extend outwardly fromthe elongate body 110 of the anchor sleeve 100. In particular, thesubcutaneous anchors 160 are shifted to the deployed position when thefirst actuator 130 is adjusted to the proximal position via the motion135 shown in FIG. 3. The first actuator 130 can be pulled by a user toslide the actuator 130 in the proximal direction along one or more guiderails 132. The movement of the first actuator 130 transmits a deploymentforce to the anchor tines 160 (via an actuator rod 164 described in moredetail below in connection with FIG. 9 and FIGS. 11-12) so that theanchor tines 160 at least partially extend out of the ports 162. Aspreviously described, the anchor tines 160 can include a convexly curvedshape that facilitates the transition from the non-deployed to thedeployed position and reduces the likelihood of damaging the undersideof the skin 20 during deployment in the subcutaneous region 24 (refer toFIG. 1). In the configuration shown in FIG. 3, the second actuator 140is maintained in the first rotational position described above inconnection with FIG. 2. As such, when the anchor tines are deployed asshown in FIG. 3, the catheter device 50 (refer to FIG. 1) can beinserted through the working channel 112 of the anchor sleeve 100 fordelivery to a targeted internal site.

As shown in FIG. 4, the anchor sleeve 100 can be adjusted to a deployedand locked configuration. In this configuration, the anchors 160 aredeployed to extend outwardly from the elongate body 110, and an internallocking device 150 (FIGS. 8-10) is activated to releasably retain thecatheter device 50 with the anchor sleeve 100. As described in moredetail below in connection with FIGS. 8-10, the internal locking device150 can be activated when the second actuator 145 is at least partiallyrotated in a movement 145 about a longitudinal axis 111. In thisembodiment, the second actuator 140 is shift from the first rotationalposition in which it is oriented transversely to the first actuator 130to a second rotational position shown in FIG. 4. When in this secondrotational position, the second actuator 140 can be oriented inalignment with the first actuator 130. For example, the second actuator140 may undergo a rotational movement 145 of approximate 90-degreesabout the longitudinal axis 111 so that the second actuator 140generally aligns with the first actuator 130. During this rotationalmovement 145, the second actuator 140 can urge the internal lockingdevice 150 (FIGS. 8-10) to act upon a portion of the catheter device 50arranged in the working channel 112 of the anchor sleeve.

In an alternative embodiment, the second actuator 140 may include one ormore structures that releasably engage the first actuator 130 when thesecond actuator 140 undergoes the movement 145 to align with the firstactuator 130. For example, the second actuator may include connectorarms (not shown in FIGS. 2-4) that mate with grooves formed in the outersurface of the first actuator 130 when second actuator 140 aligns withthe first actuator 130. In such circumstances, the first actuator 130would be locked in its proximal position (with the anchor tines 160 inthe deployed position) while the second actuator 140 is in the secondrotational position as shown in FIG. 4 (with the anchor sleeve 100locked with the catheter device 50). Thus, in this embodiment, theanchor tines 160 could be retracted into the elongate body 110 onlyafter the second actuator 140 is rotated back to the first rotationalposition (FIGS. 2-3), thereby unlocking the first actuator 130 from thegrasp of the second actuator 140 and unlocking the catheter device 50from the anchor sleeve 100.

Referring now to FIGS. 5-7, the movements of the first and secondactuators 130 and 140 are illustrated from a bottom view that shows theanchor deployment ports 162. As shown in FIG. 5, the anchor sleeve 100can be arranged in the non-deployed and non-locked configuration (aspreviously described in connection with FIG. 2). In this configuration,the anchors 160 are retracted into an internal space of the elongatebody 110 so that the anchor deployment ports 162 are viewable. Thesubcutaneous anchors 160 can be arranged in this non-deployed positionshown in FIG. 5 prior to insertion of the anchor sleeve 100 so as tominimize resistance and possible damage to the skin 20 when the elongatebody inserted through the skin entry site 22.

As shown in FIG. 6, the anchor sleeve 100 can be shifted to the deployedand non-locked configuration (as previously described in connection withFIG. 3). As such, when the anchor sleeve 100 has been inserted to theintended depth inside the subcutaneous layer 24, the anchors 160 can beshifted to the deployed position to provide at least temporary anchoringfor the anchor sleeve 100. In particular, the subcutaneous anchors 160are shifted to the deployed position when the first actuator 130 isadjusted to the proximal position via the longitudinal motion 135. Themovement of the first actuator 130 transmits a deployment force to theanchor tines 160 (via an actuator rod described in more detail below inconnection with FIGS. 8-10) so that the anchor tines 160 extend out ofthe ports 162. In this configuration shown in FIG. 6, the secondactuator 140 may be spaced apart from the first actuator 130 by a gap136. This gap 136 can be closed when the second actuator 140 undergoesis partial rotational movement 145, as described below.

As shown in FIG. 7, the anchor sleeve 100 can be adjusted to thedeployed and locked configuration (as previously described in connectionwith FIG. 4). In this configuration, the second actuator 140 is shiftedfrom the first rotational position (FIG. 6) to the second rotationalposition (FIG. 7) by the rotational movement 145 about the longitudinalaxis 111. During this rotational movement 145, the second actuator 140also closes the longitudinal gap 136 between the second actuator 140 andthe first actuator 130. For example, the second actuator 140 may be in athreaded engagement with the elongate body 110 or another internalstructure so that the rotational movement 145 also translates into asmall longitudinal shift to at least partially close the gap 136 (FIG.7). In some embodiments, this secondary longitudinal motion of thesecond actuator 140 can be used to urge the internal locking device 150(FIGS. 8-10) to act upon a portion of the catheter device 50. Thus, theuser can receive the benefit of the mechanical advantage provide by thetwisting action of the second actuator 140 so as to provide asignificant force the causes the locking device 150 to retain thecatheter device in place. Moreover, the locking device 150 can be usedto form a seal around the catheter device, as described in more detailbelow.

Referring now to FIGS. 8-10, the adjustment of the first actuator 130and second actuator 140 can cause a number of internal structures tomove within the anchor sleeve 100. In particular, the first actuator 130can be adjusted to cause an actuation rod 164 to move within an internalactuator channel 113. Also, the second actuator 140 can be adjusted tocause a locking device 150 to lock with a portion of the catheter device50 arranged in the working channel 112. The operation of the lockingdevice 150 is described in more detail below in connection with FIG. 10.It should be understood from the description herein that the catheterdevice 50 is removed from view in FIGS. 8-10 for purposes ofillustrating the working channel 112.

As shown in FIG. 8, the anchor sleeve 100 can be arranged in thenon-deployed and non-locked configuration so that the anchors 160 areretracted into an internal space of the elongate body 110 (as previouslydescribed in connection with FIG. 2). The elongate body 110 of theanchor sleeve 100 can comprise a biocompatible material, such as PEEK(polyetheretherketone), polyethylene, polyimide, or the like. The body110 may have a modified elliptical cross-sectioned shape and may includea taper along the distal portion 115 that facilitates insertion of theanchor sleeve 100 through the skin entry site 22.

In some embodiments, the anchor sleeve 100 can include one or moreinternal channels 112 and 113. For example, the anchor sleeve 100 mayinclude the working channel 112 to receive the catheter device 50 orother medical instrument, and may also include an actuator channel 113to accommodate the actuation of the subcutaneous anchors 160. Theworking channel 112 can extend through the entire length of the anchorsleeve 100 from the distal tip portion 115 to the proximal portion 116.After insertion of at least a portion of the elongate body 110 into thesubcutaneous region 24 (FIG. 1), the working channel 112 can be used tointroduce the catheter device 50 or other medical instrument into apatient. Thus, the catheter device 50 can be introduced into the workingchannel 112 at the proximal portion 116 and advanced through theelongate body 110 until it emerges from the distal tip portion 115.

In the embodiment depicted in FIGS. 8-10, the anchor sleeve 100 containsa single, round working channel 112. The working channel 112 is sized toreceive at least one catheter device 50 or other medical instrument. Insome embodiments, the working channel 112 can have a diameter of about 3French to about 30 French, and about 5 French to about 20 French,including particular ranges from about 3 French to about 7 French andabout 12 French to about 17 French. As such, the working channel 112 canaccept a wide range of catheters and medical instruments. In alternateembodiments of the anchor sleeve 100, the working channel 112 can have adifferent shape or size. For example, the working channel 112 may have across-sectional shape in the form of a square or other polygon thatmates with the medical instrument to be passed therethrough. Also, theworking channel 112 need not be a single lumen. In alternateembodiments, the anchor sleeve 100 may include multiple workingchannels, such as adjacent channels or coaxial channels that permit theintroduction of multiple medical instruments (e.g., catheters,endoscopes, or the like). Furthermore, the multiple working channels maybe selectively sealable so that one working channel could be accessedwhile another is sealed. In such cases, it would be possible tointroduce and secure several catheters at different points in time.

The actuator channel 113 of the anchor sleeve 100 is formed in theelongate body 110 and can movably receive an actuator rod 164. Theactuator channel 113 may be defined by one or more side walls that canslidably engage the actuator rod 164. Movement of the actuator rod 164within the actuator channel 113 can urge the anchors 160 to extend from,or retract into, the deployment ports 162. In this embodiment, thecross-sectional shape of the actuator channel 113 and the actuator rod164 may be quadrilateral to permit longitudinal movement of the actuatorrod 164 while hindering possible rotational movement of the actuator rod164 about its longitudinal axis.

Referring to FIG. 9, the first actuator 130 can undergo the previouslydescribed movement 135 to cause the actuator rod 164 to move within theactuator channel 113 in a longitudinal direction of the sleeve device100. The actuator rod 164 may include a connector 167 that is coupled tothe actuator 130 (described below in connection with FIGS. 11-12). Assuch, movement of the first actuator 130 can be translated to theactuator rod 164. The actuator rod 164 has a distal end 166 that can beadvanced and retracted within the actuator channel 113 in response tothe movement of the first actuator 130. The anchors 160 can be coupledto the actuator rod 164 such that movement of the actuator 130 (and thecorresponding translation of the actuator rod 164 within the actuatorchannel 113) causes the anchors 160 to shift between the non-deployedposition (FIG. 8) and the deployed position (FIG. 9).

The actuator channel 113 may not extend fully through the body 110 ofthe anchor sleeve 100. For example, the actuator channel 113 may extenddistally to a depth that extends to a terminal end 114. In someembodiments, when the first actuator 130 is shifted to the distalposition (FIG. 8), the anchor actuator rod 164 is caused to advancewithin the anchor actuator channel 113 such that the distal end 166 ofthe actuator rod 164 approaches the terminal end 114 of the actuatorchannel 113. In this embodiment, the anchors 160 are coupled to theactuator rod 164 so that the anchors 160 retract into the body 110 asthe distal end 166 of the rod 164 approaches the terminal end 114(shifts to the non-deployed state). In such circumstances, the anchors160 may be flexed to a stressed condition while retained within theactuator channel 113 or other internal space of the elongate body 110.

Referring again to FIG. 9, the first actuator 130 can be pulled togenerate the longitudinal movement 135, and this movement 135 istranslated to the actuator rod 164 via the connector portion 167. Theactuator rod 164 slides within the actuator channel 113 so that thedistal end 166 of the rod 164 shifts away from the terminal end 114.This motion of the actuator rod 164 causes the tips of the anchor tines160 to pass through the deployment ports 162 in an outward movement 165to extend outwardly from the elongate body 110. It should be understoodfrom the description herein that, in alternative embodiments, theactuator rod 164 and anchors 160 could be configured so that pulling thefirst actuator 130 to the proximal position would cause the anchors 160to transition to their non-deployed state, while pressing the firstactuator 130 into the distal position would cause the anchors 160 totransition to the deployed state.

As shown in FIG. 10, the anchor sleeve 100 can be adjusted to thedeployed and locked configuration (as previously described in connectionwith FIG. 4). In this configuration, the second actuator 140 causes thelocking device 150 to act upon a portion of the catheter device 50 so asto lock the anchor sleeve to the catheter device 50. As previouslydescribed, the catheter device 50 is removed from view in FIGS. 8-10 forpurposes of illustrating the working channel 112. The second actuator140 is shifted from the first rotational position (FIGS. 8-9) to thesecond rotational position (FIG. 10) by the rotational movement 145about the longitudinal axis 111. During this rotational movement 145,the second actuator 140 also closes the longitudinal gap 136 (FIG. 9)between the second actuator 140 and the first actuator 130. In thisembodiment, the second actuator 140 include an internal thread pattern147 that mates with an external thread pattern 117 on the elongate body110 or another internal structure. As such, the rotational movement 145of the second actuator 140 also translates into a small longitudinalmovement that closes the gap 136 (FIG. 9). This secondary longitudinalmotion of the second actuator 140 can be used to urge the internallocking device 150 to act upon a portion of the catheter device 50.

Accordingly, the user an receive the benefit of the mechanical advantagefrom the twisting action of the second actuator 140 so as to provide asignificant force the causes the locking device 150 to be compressedaround an outer surface of the catheter device 50. This compression ofthe locking device 150 can also form a seal around the catheter device50. For example, in some embodiments, the locking device 150 maycomprise a cylindrical seal formed of a flexible material, such assilicon. As shown in FIG. 10, the cylindrical seal 150 can be arrangedbetween an internal surface 148 of the second actuator 140 and anopposing surface 118 of the elongate body 110. Accordingly, the movement140 of the second actuator 140 can cause the cylindrical seal to becompressed between the opposing surfaces 148 and 118. Such compressioncauses the cylindrical member 150 to flex inwardly (refer to FIG. 10)and engage the catheter device 50 to thereby compress around an outersurface of the catheter device 50. Thus, the locking device 150 engagesthe catheter device 50 to lock it in place relative to the anchor sleeve100. Furthermore, the locking device 150 can form a seal around theouter surface of the catheter device 50 when it is compressed around thecatheter device 50.

It should be understood from the description herein that the lockingdevice 150 is not limited to the embodiments of the cylindrical polymerseal. For example, some embodiments of the locking device may includefirst and second jaws that operate to clamp upon the outer surface ofthe catheter in response to adjustment of the second actuator 140.Furthermore, in these embodiments, the locking device may include one ormore seal members arranged between the opposing surfaces of the jaws.For example, a silicone seal having a half-cylinder shape can be affixedto the inner cylindrical face of the first jaw, and an opposing siliconeseal having a half-cylinder shape can be affixed to the innercylindrical face of the second jaw. As such, the opposing seal memberswould surround and compress the outer surface of the catheter arrangedin the working channel 112.

Referring now to FIGS. 11-12, the actuation rod 164 and the firstactuator 130 can be coupled to one another so that the movement 135(FIG. 9) of the first actuator 130 results in a corresponding movementof the actuation rod 164. In this embodiment, the actuation rod 164includes a connector 167 that mates with a complementary connector 137(FIG. 12) of the first actuator 130. The connection can be configured totransmit a longitudinal force from the first actuator 130 to theactuation rod 164, thereby directing the anchor tines 160 to extend fromor retract into the elongate body 110 (FIGS. 8-9). As previouslydescribed in connection with FIGS. 8-9, the anchors 160 are coupled tothe actuator rod 164 so that the anchors 160 retract into the elongatebody 110 as the distal end 166 of the rod 164 approaches the terminalend 114 (shifts to the non-deployed state). The anchors 160 can beintegrally formed with the actuator rod 164 (e.g., formed from a nitinolmaterial or the like). It should be understood from the descriptionherein that, in some embodiments, the anchors 160 can be joined with theactuation rod 220 at a location other than the distal end 224. Forexample, in other embodiments, the anchors 160 may be connected to theactuator rod 220 along a middle region of the rod 220. Also, inalternative embodiments, the anchors 160 may be non-integral with theactuator rod 220. For example, the anchors may be formed separately fromthe actuator rod 220 and then mounted to the rod 220 using an adhesive,a weld, a connector, or the like.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. An anchor sleeve device, comprising: an elongate body that defines atleast one working channel extending from a proximal opening to a distaltip opening so as to receive a catheter; a subcutaneous anchor mechanismcoupled to the elongate body, the subcutaneous anchor mechanism havingone or more flexible anchors that extend outwardly away from a wall ofthe elongate body when in a deployed orientation in a subcutaneouslayer; a first actuator that is adjustable relative to the elongate bodyso as to shift the flexible anchors to the deployed orientation; alocking device that releasably engages to the catheter when the catheteris received in the working channel; and a second actuator that isadjustable relative to the elongate body so as to urge the lockingdevice to compress at least a portion of an outer surface of thecatheter when the catheter is received in the working channel.
 2. Theanchor sleeve of claim 1, wherein the first actuator is a slider devicethat reciprocates in a direction substantially parallel to alongitudinal axis of the elongate body.
 3. The anchor sleeve of claim 2,wherein the second actuator is a twist device that at least partiallyrotates about the longitudinal axis of the elongate body.
 4. The anchorsleeve of claim 1, wherein the flexible anchors are movable from anon-deployed orientation to the deployed orientation, the flexibleanchors being flexed to a stressed condition when in the non-deployedorientation.
 5. The anchor sleeve of claim 4, wherein the flexibleanchors are retracted into an internal space of the elongate body whenin the non-deployed orientation.
 6. The anchor sleeve of claim 5,wherein the flexible anchors exhibit superelastic characteristics toflexibly return to the deployed orientation in response to movement ofthe first actuator.
 7. The anchor sleeve of claim 1, wherein thesubcutaneous anchor mechanism at least temporarily retains the elongatebody in engagement with a skin insertion site when the flexible anchorsare in the deployed orientation in the subcutaneous layer.
 8. The anchorsleeve of claim 7, wherein the first actuator is movable between a firstposition that causes the flexible anchors to be retracted into aninternal space of the elongate body during passage through a skinsurface and a second position that causes the flexible anchors toextended toward the deployed orientation under the skin surface and inthe subcutaneous region.
 9. The anchor sleeve of claim 8, wherein thesecond actuator is movable between a first position that causes theelongate body to slidably receive the catheter and a second positionthat urges the locking device to releasably lock with the catheter whenthe catheter is received in the working channel.
 10. The anchor sleeveof claim 9, wherein the locking device comprises a polymeric member thatis compressed upon an outer surface of the catheter device in responseto the adjustment of the second actuator when the catheter is receivedin the working channel.
 11. The anchor sleeve of claim 10, wherein thelocking device comprises a silicon cylindrical member that provides aseal around the outer surface of the catheter when the catheter isreceived in the working channel.
 12. The anchor sleeve of claim 1,wherein the first actuator isolates a user-applied force to urge theflexible anchors toward the deployed orientation and the second actuatorisolates a user-applied force required to urge the locking device toreleasably lock with the catheter when the catheter is received in theworking channel.
 13. A method of delivering a catheter device to aninternal body site, comprising: advancing an anchor sleeve through apercutaneous opening so that one or more subcutaneous anchor tines aredisposed adjacent to a subcutaneous region; advancing a catheter devicethough a working channel of the anchor sleeve and toward a targeted bodysite, the catheter device defining at least one lumen that extends to acatheter tip; operating a first actuator to deploy the subcutaneousanchor tines into the subcutaneous region; and operating a secondactuator to urge a locking device releasably lock with the catheter whenthe catheter is received in the working channel.
 14. The method of claim13, wherein the anchor sleeve is releasably secured to a skin regionproximate the percutaneous opening when the subcutaneous anchor tinesare deployed into the subcutaneous region.
 15. The method of claim 14,wherein the subcutaneous anchor tines are retracted into an internalspace of the anchor sleeve when the anchor sleeve is advanced throughthe percutaneous opening.
 16. The method of claim 15, wherein thesubcutaneous anchor tines exhibit superelastic characteristics toflexibly adjust to a deployed orientation when the first actuator isoperated to deploy the subcutaneous anchor tines into the subcutaneousregion.
 17. The method of claim 13, wherein operating the first actuatorcomprises moving a slider device that reciprocates in a directionsubstantially parallel to a longitudinal axis of the anchor sleeve. 18.The method of claim 17, wherein operating the second actuator comprisesmoving a twist device that at least partially rotates about thelongitudinal axis of the anchor sleeve.
 19. The method of claim 13,wherein the first actuator is operated to deploy the subcutaneous anchortines into the subcutaneous region by application of a firstuser-applied force, and the second actuator is operated to urge thelocking device to releasably lock with the catheter by application of asecond user-applied force, the first user-applied force being isolatedfrom the second user-applied force.
 20. The method of claim 13, whereinthe locking device releasably locks with the catheter by compressing atleast a portion of an outer surface of the catheter when the catheter isreceived in the working channel.